Senior Staff Engineer, Hardware at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

06 May, 26

Salary

210000.0

Posted On

05 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Design, Problem Solving, Injection Molding, DFM, DFA, Materials Selection, Verification, Test Methods, Lean Six Sigma, Failure Analysis, Tolerance Analysis, GD&T, Robustness Engineering, Cross-Functional Leadership, Statistical Thinking, 3D CAD

Industry

Medical Equipment Manufacturing

Description

Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Position Summary: Werfen is seeking a Senior Staff Mechanical Engineer to provide technical leadership and continuous process improvement. This role is a senior-level individual contributor position responsible for defining and driving process improvement, detailed design, and technical decision-making from feasibility through verification/validation, design transfer, and lifecycle support. The Senior Staff Mechanical Engineer is expected to operate with a high degree of autonomy and raise the technical bar through robust engineering practices and disciplined design control execution. The pay range for this role is between $175,000 and $210,000 per year, depending on experience. Responsibilities Key Responsibilities: Responsible for the resolution of production process issues utilizing problem-solving techniques to analyze, identify root cause(s), develop and implement solutions. Technical Ownership (Consumable Mechanical Subsystem): Serve as the mechanical technical owner for consumable assemblies and interfaces, ensuring end-to-end production process performance, reliability, manufacturability, and cost targets. Design Controls Excellence: Author and maintain high-quality design inputs/outputs, DHF documentation, DFMEA/PFMEA, verification evidence, and change records compliant with Werfen QMS and applicable standards. Drive DFM/DFA, tooling strategy, and manufacturing readiness activities; partner with Operations and suppliers to ensure scalable high-volume production and robust process windows. Materials/Process Selection for Consumables: Select and validate materials and processes appropriate for consumables (polymers, films, adhesives, seals, welded joints). Verification, Test Methods & Fixtures: Define verification strategy, develop test methods, fixtures, gage strategies, and data analysis to support traceable verification conclusions. Lifecycle/Sustaining Support: Lead investigations and resolution of field/manufacturing issues (RCA, CAPA support, design changes), ensuring effective improvements are implemented. May lead or participate in Lean Six Sigma projects of significant scope and complexity. Networking/Key relationships Builds strong working relationships with Systems Engineering and Assay Development. Quality / Regulatory: Supplier Quality, Quality Engineering, Regulatory Affairs (support for technical documentation and compliance). Operations: Manufacturing Engineering, NPI/Design Transfer, Production, Packaging Engineering, Supply Chain/Procurement. External: Key suppliers/contract manufacturers (tooling, molding, assembly, materials), metrology labs, and test partners. Qualifications Skills & Capabilities: Strong engineering fundamentals in injection molding processes, plastic welding, precision mechanical design, tolerance analysis, GD&T, materials selection, failure analysis, and robustness engineering. Deep experience applying DFM/DFA for high-volume manufacturing; automation, tooling strategy and ramp support. Proven ability to translate requirements into design solutions and deliver traceable verification evidence within a design controls framework. Strong problem-solving methods (structured RCA, hypothesis-driven experimentation, statistical thinking) with a record of closing complex issues. Comfortable leading cross-functional technical reviews and making sound tradeoffs balancing performance, reliability, schedule, cost, and risk. Excellent written and verbal communication skills; able to produce clear, audit-ready documentation and concise executive-ready updates. Proficiency with modern mechanical engineering tools (AI, 3D CAD, drawing standards, PDM/PLM, test/measurement methods; analysis tools such as FEA are a plus). Minimum Knowledge & Experience required for the position: Bachelor’s degree in Mechanical Engineering or related discipline required (M.S. or higher preferred). Typically, 10+ years of progressive mechanical engineering experience with multiple full product development cycles; medical device and/or regulated product development strongly preferred. Significant experience owning subsystem or product-level mechanical scope through V&V and design transfer into manufacturing. Experience with consumables-relevant manufacturing processes strongly desired (e.g., injection molding, film/lamination handling, ultrasonic/thermal welding, adhesives, sealing technologies, precision assembly). Working knowledge of regulated development expectations (e.g., ISO 13485, 21 CFR 820, and risk management practices aligned with ISO 14971). Experience in Lean and Six Sigma problem-solving methodologies is preferable. Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

The Senior Staff Mechanical Engineer is responsible for resolving production process issues and ensuring the performance and reliability of consumable assemblies. This role involves driving process improvement and technical decision-making throughout the product lifecycle.